Risperidone tablet — supplier from India to the UK, GCC and Africa.
A WHO Essential Medicines List atypical antipsychotic for schizophrenia, bipolar I mania and short-term persistent aggression. Film-coated tablets in 0.25mg to 6mg from Indian WHO-GMP partner sites, with the CTD dossier, batch documentation and tender pack a mental-health buyer expects.
Seven tablet strengths · WHO EML core antipsychotic · full CTD dossier on file.
Active ingredient
Risperidone, a second-generation (atypical) antipsychotic. Combined dopamine D2 and serotonin 5-HT2A antagonist with secondary alpha-1, alpha-2 and H1 affinity. The active metabolite 9-hydroxyrisperidone (paliperidone) contributes measurably to effect.
Strengths stocked
Film-coated tablets in 0.25mg, 0.5mg, 1mg, 2mg, 3mg, 4mg and 6mg. Oral administration per destination-country labelling. Strength-specific blister colour coding on request for dispensary safety.
Indications
Schizophrenia in adults and adolescents from 13 years; acute manic episodes in bipolar I disorder; short-term (up to 6 weeks) persistent aggression in conduct disorder from 5 years; short-term persistent aggression in Alzheimer's dementia, severe cases only. Per MHRA and EMA SmPC.
Storage
Store below 25-30°C in the original packaging, protected from moisture. No cold-chain required — risperidone tablets ship under standard ambient pharmaceutical freight. The blister wallet itself is the primary moisture barrier.
Shelf life
36 months from date of manufacture. Minimum 24 months at dispatch on named orders, longer on made-to-order batches. Or we won't ship it.
Pack format
PVC/PVdC-aluminium blister wallets — 28-tablet calendar packs for NHS monthly dispensing, 60-tablet packs for retail and hospital outpatient. HDPE bottles (500 and 1,000 tablet fills) with induction seal and child-resistant closure for tender bulk.
NHS trust pharmacies, MoH tender desks and NGO mental-health programmes across twenty markets.
India is our origin. We do not sell into the Indian market. Risperidone is exported only.
United Kingdom
NHS mental-health trust pharmacies and wholesalers under standard generic supply, and specialist importers under the MHRA (Medicines and Healthcare products Regulatory Agency) Specials / named-patient route where a patient-specific unlicensed import is needed. Calendar blister packs and bulk bottles prepared to MHRA SmPC labelling conventions.
GCC (UAE, KSA, Kuwait, Oman, Qatar, Bahrain)
Through licensed local importers, against hospital psychiatry-unit POs and MoH tender awards. CTD dossiers prepared for SFDA (Saudi Food & Drug Authority), MOHAP (UAE Ministry of Health and Prevention) and GCC central registration. Arabic PIL and destination-language cartons on file.
Nigeria, Kenya, Ghana, South Africa
Public-sector mental-health tenders and teaching-hospital supply — NAFDAC (Nigeria), PPB (Pharmacy and Poisons Board, Kenya), CMS, and SAHPRA (South African Health Products Regulatory Authority) routes. WHO EML core-list evidence supports Global Fund and NGO procurement pathways including MSF psychiatric programmes.
Germany
Supply via licensed German importers under §72 AMG, with Qualified Person (QP) certification on arrival. CTD dossier and Certificate of Pharmaceutical Product prepared for BfArM (German federal institute for drugs) recognition. German-language PIL to current labelling standards.
What the dispensing pharmacist actually needs to flag.
Risperidone is a CYP2D6 substrate with a pharmacologically active 9-hydroxy metabolite (paliperidone), so co-prescription with strong inhibitors — paroxetine, fluoxetine, bupropion — raises total active moiety exposure by roughly 50% and a dose review is warranted. CYP3A4 inducers (carbamazepine, rifampicin, phenytoin) cut exposure significantly; a dose increase is often needed. Metabolic monitoring is the real clinical work: weight, fasting glucose, HbA1c and lipid profile at baseline, 3 months and 12 months, per NICE and APA. Hyperprolactinaemia is more common than with aripiprazole, quetiapine or olanzapine — amenorrhoea, galactorrhoea, sexual dysfunction and chronic-use osteoporosis risk should all be flagged at counselling. Orthostatic hypotension bites in early titration, especially in older patients; start 0.25-0.5mg BD in the elderly. The dementia-aggression indication carries a black-box increased-mortality warning and is limited to severe cases, up to 6 weeks. Taper on discontinuation — abrupt stops risk cholinergic rebound and withdrawal dyskinesia.
The documentation pack a mental-health tender actually asks for.
Our role is manufacturer-facing. We sit between the Indian WHO-GMP facility and your trust pharmacy, MoH tender desk or NGO procurement team and take the paperwork off both sides.
CTD Module 3
Full chemistry, manufacturing and controls section, prepared in eCTD-ready format where the importing authority accepts it. Module 2 quality overall summary included. Dissolution, assay and related-substances data per ICH Q6A.
CoA and MoA, per batch
HPLC assay, related substances, uniformity of dosage units, dissolution, water content and microbiological limits — signed by the manufacturer's authorised QC head on every batch.
CoPP, WHO-GMP, MFG licence
Certificate of Pharmaceutical Product, WHO-GMP certificate and manufacturing licence issued by CDSCO (Central Drugs Standard Control Organization, India) and apostilled where the destination requires it. Notarised copies in the shipping pack.
Pack insert, labels, artwork
Destination-language patient information leaflet, labelling to local regulator standards (MHRA SmPC style for the UK, MoH style for GCC, SAHPRA for South Africa, BfArM for Germany). Artwork QC before print, not after.
Temperature control
Ambient pharmaceutical freight — no cold-chain required for tablets. Pre-shipment packaging qualification, in-transit tracking on request, on-arrival inspection with a signed record. Excursion thresholds defined before dispatch.
Pharmacovigilance
Local PV partner or a named PV contact organised in the destination market against registration. Periodic Safety Update Reports compiled to ICH E2C. Pregnancy and lactation reporting pathways defined for mental-health indications.
Complete the mental-health formulary.
Most psychiatric and neurology buyers procure risperidone alongside other antidepressants, antipsychotics and antiepileptics. We carry the full CNS cluster.
Amitriptyline
Tricyclic antidepressant, neuropathic pain and depression. 10mg / 25mg / 50mg tablets.
Citalopram
SSRI, first-line depression and anxiety. 10mg / 20mg / 40mg tablets + oral drops.
Donepezil
Cholinesterase inhibitor, Alzheimer's disease. 5mg / 10mg tablets + ODT.
Olanzapine
Second-gen antipsychotic, schizophrenia and bipolar. 2.5mg to 20mg tablets.
Pregabalin
Gabapentinoid, neuropathic pain and GAD. 25mg to 300mg capsules.
All CNS & neurology →
85+ CNS SKUs: antidepressants, antipsychotics, antiepileptics, dementia.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Strength, tablet count, pack format (calendar blister or HDPE bulk bottle), destination market, whether it is tender, trust pharmacy or wholesaler, and the target delivery window.
- We route to the right line. Multiple WHO-GMP partner lines sit on the M Care roster for risperidone. Registered-market preference goes to facilities with in-country registration; tender work goes to the line with the right price point and label capability.
- Commercial and regulatory offer. FOB / CIF price, lead time, a dossier status note per destination, and the documentation pack you can expect with the shipment. Inside one working day.
- Order, produce, release, ship. QC release on the Indian side. Standard ambient pharmaceutical freight, no cold-chain. Tamper-evident induction seals on HDPE bottles for tender bulk; shrink-sleeve tamper-evidence on hospital cartons. Photo evidence of seal integrity on request.
- After delivery. Batch records, Certificate of Analysis and shipment documentation archived for the full shelf life of the consignment. Pharmacovigilance contact opened on registration for adverse-event reporting and PSUR compilation.
Risperidone tablet supply — the specific questions.
What strengths of risperidone tablet do you supply?
Film-coated tablets in 0.25mg, 0.5mg, 1mg, 2mg, 3mg, 4mg and 6mg. Pack formats are PVC/PVdC-aluminium blister wallets (28 tablets for NHS monthly dispensing, 60 tablets for retail and outpatient hospital) and HDPE bottles of 500 or 1,000 tablets for tender bulk. Strength-specific blister colour coding is available to reduce dispensary selection errors. The oral solution 1mg/ml and orally disintegrating tablet formulations are available separately on request — this page covers film-coated tablets only.
Do you supply the long-acting injectable risperidone (Consta) from the same line?
No. This page covers risperidone film-coated tablets only. The long-acting injectable risperidone formulation (branded originator Risperdal Consta and generic equivalents) is a different dosage form — microsphere suspension for deep intramuscular injection every two weeks — with very different supply economics, cold-chain requirements (2-8°C) and regulatory pathway. We can quote long-acting injectable supply separately against a dedicated enquiry. Send the destination market, strength (12.5mg / 25mg / 37.5mg / 50mg), vial volume and target delivery window and the Mumbai desk will come back with a separate offer.
Which markets can you ship risperidone tablets into?
We routinely ship into the UK (NHS mental-health trust pharmacies through wholesalers, or the MHRA Specials / named-patient route where a patient-specific unlicensed import is needed), the GCC through licensed local importers against hospital psychiatry-unit and MoH tender awards, sub-Saharan Africa (Nigeria, Kenya, Ghana, South Africa — tender and teaching-hospital supply, plus Global Fund and NGO mental-health programmes), and Germany under §72 AMG import channels. We do not supply into India.
Is risperidone on the WHO Essential Medicines List, and does that help with tenders?
Yes. Risperidone is on the WHO Essential Medicines List as a core antipsychotic for schizophrenia, and appears on national EMLs across the markets we supply. WHO EML core-list status is often a prequalifier on Global Fund, MSF and African Ministry of Health psychiatric tenders, and it simplifies the evidence burden for mental-health programme procurement. We can supply WHO EML evidence, WHO-GMP certification and a dossier mapped to WHO-PQ expectations where a tender specifies the pathway. Full list under CNS & neurology.
What documentation is included with a risperidone consignment?
Every consignment ships with a batch-specific Certificate of Analysis, Method of Analysis, Certificate of Pharmaceutical Product where required, WHO-GMP certificate, CDSCO manufacturing licence, Certificate of Origin (chamber-attested), destination-language patient information leaflet and carton artwork, and a dispatch-to-arrival shipment record. A named pharmacovigilance contact is nominated in the destination market on registration.
Do you provide CTD dossiers for risperidone registration?
Yes. Full CTD Module 3 dossiers are available against NDA, for registration with MHRA, GCC central registration, SFDA, MOHAP, NAFDAC, PPB, SAHPRA, BfArM and equivalents. Module 2 quality overall summary and Module 1 administrative sections are prepared in destination-specific format. See dossier preparation.
What are typical lead times for risperidone tablet orders?
For registered markets with stock on hand, dispatch is typically 5-10 working days from confirmed order. Made-to-order batches with destination-specific artwork run 6-10 weeks inclusive of QC release and carton print. Air-freight transit to the UK or GCC: 3-5 days; sea-freight to Africa: 18-28 days. No cold-chain means routing flexibility — we can split consignments across air and sea where a tender timeline needs a priority tranche followed by bulk.
Send the specifics. You'll have a price inside one working day.
Strength, volume, pack format, destination, tender or hospital pharmacy, target delivery. That's the enquiry. Everything else is on us.